Manufacturer Communications: Industry Seeks Single Evidentiary Standard

‘Competent and reliable scientific evidence’ standard for payer communications also should apply to medical product communications that are consistent with labeling, manufacturers say in comments on US FDA draft guidance documents.

Biopharma companies want FDA to apply a single evidentiary standard to two types of drug manufacturer communications.

In comments on two agency draft guidances, industry groups and individual companies urge FDA to harmonize its evidentiary standards for medical product communications that are consistent with approved

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